FDA 510(k) Application Details - K012299

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K012299
Device Name Implant, Endosseous, Root-Form
Applicant BASIC DENTAL IMPLANT SYSTEMS, INC.
3321 COLUMBIA, N.E.
ALBUQUERQUE, NM 87107-2001 US
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Contact DAN BLACKLOCK
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 07/20/2001
Decision Date 08/01/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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